Aflunov: Withdrawal of the marketing authorisation application

prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) (A/VietNam/1194/2004)

Overview

On 13 June 2008, Novartis Vaccines and Diagnostics S.r.l. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Aflunov, for the prophylaxis of H5N1 avian influenza in adults and the elderly.

  • List item

    Questions and answers on the withdrawal of the marketing application for Aflunov (PDF/40.46 KB)


    First published: 03/07/2008
    Last updated: 03/07/2008
    EMEA/306731/2008

  • Key facts

    Name
    Aflunov
    Product number
    EMEA/H/C/000804
    International non-proprietary name (INN) or common name
    • prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) (A/VietNam/1194/2004)
    Active substance
    • prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) (A/VietNam/1194/2004)
    Date of withdrawal
    13/06/2008
    Company making the application
    Novartis Vaccines and Diagnostics S.r.l.
    Withdrawal type
    Initial authorisation

    All documents

    Related information on withdrawals

    A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter (withdrawal letter Doc. type, leave the 'Author' in properties blank).

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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